The year gone by saw the highest number of generic drug approvals by the US Food and Drug Administration (FDA), along with the most ever novel drugs (46); the most ever novel devices, and the first ever gene therapies.
In 2017, 46 new molecular entities (NMEs) were approved by the FDA , and that excludes the pathbreaking CAR-T and gene therapies.
The Europe 92 new drugs were recommended for approval, including generics, up from 81 in 2016, and China announced plans to speed up approvals in what is now the world’s second biggest market behind the United States.
In August, the FDA had approved Novartis’ Kymriah (tisagenlecleucel), the first-ever gene therapy — known as CAR-T (short for chimeric antigen receptor T-cell) — for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). And in October, the FDA approved the second CAR-T cell therapy — Yescarta (axicabtagene ciloleucel) — for treating adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.
Until mid-December, the FDA had approved 765 generic drugs, as opposed to 630 copycats approved in 2016. This made 2017 the industry’s most productive of the last five years. However, analysts warn that 2018 will see more pricing woes for generic companies.
In 2018, PharmaCompass expects to continue witnessing this activity as the FDA seeks to encourage more competition for generic drugs and works on accelerating approvals for novel medicines. In December, the FDA provided an updated list of 319 drugs for which US patents have expired but have no generic copies.
In 2017, 51 devices received clearance from the FDA. Besides a handful of diagnostic devices, disease management platforms, and novel monitors, the year also saw the approval of direct-to-consumer genetic tests for disease risk and a purely digital intervention.
Medtronic received FDA clearance for its sensor-enabled single-use vest with 252 electrode sensors that provide electroanatomic 3D maps of the upper and lower chambers of the heart, and works by pairing body surface electrocardiogram (ECG) signals from the chest.
The FDA also gave its nod to California-based ResMed’s small and portable continuous positive airway pressure (CPAP) device — AirMini. A non-prescription version of BlueStar (a diabetes management platform from WellDoc) also received the FDA’s nod.
Besides these devices, a mobile application from Eli Lilly — known as Go Dose — for its rapid-acting insulin Humalog also got a green signal from the FDA.
VivaLnk, a Santa Clara-based connected health startup, received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout.
2017 saw drop in data-integrity violations, rise in improper handling of OOS results
As we reached 2017-end, we witnessed a reduction in data-integrity violations uncovered at pharmaceutical manufacturers due to the absence of the implementation of audit trail software in quality control testing equipment. However, the implementation of audit trails has resulted in the emergence of a new failing – the improper handling of out-of-specification (OOS) results.
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